Kornimate/medical-research-clean huggingface dataset:
segmentectomy versus lobectomy in t1c non-small cell lung cancer (seltic)

Conditions: Non-Small Cell Lung Cancer

Summary: the goal of this clinical trial is to investigate the role of segmentectomy in clinical t1c (2-3 cm) non-small cell lung cancer (nsclc). the main questions we aim to answer are: 1. is segmentectomy non-inferior to lobectomy in ct1c nsclc in terms of overall and recurrence free survival? 2. what are the mortality and morbidity rates of segmentectomy compared to lobectomy? researchers will compare segmentectomy and lobectomy in terms of overall and recurrence free survival. participants will: * undergo either pulmonary lobectomy or segmentectomy with mediastinal nodal dissection * be followed up with a chest ct in every 3 months in first year, every 6 months in second year and every year for following 3 years


Eligibility criteria:
inclusion criteria: * clinical t1c nsclc * parenchymal nodule \>2 cm in diameter * parenchymal nodule ≤3 cm in diameter * consolidation / tumor rate (ctr) ≥ 0.50 * definitive pathological diagnosis of nsclc preoperative or intraoperatively * no evidence of distant metastasis * no evidence of n2 disease * adequate pulmonary functions for lobectomy or segmentectomy exclusion criteria: * pure ggo lesions * pathologic diagnosis other than nsclc * technically not suitable for simple or complex segmentectomy, or lobectomy * evidence of distant metastasis * pathologically confirmed n2 or n3 disease * major comorbidity that precludes surgery * intraoperative mediastinal nodal dissection of less than 3 lymph node stations * prior malignancy in five years

Keywords: non-small cell lung cancer t1c segmentectomy lobectomy
protein, nutrition and cardiovascular disease in stage 5 chronic kidney disease

Conditions: End Stage Renal Disease

Summary: national kidney foundation guidelines recommend a dietary protein intake of 1.2 grams per kilogram per day (g/kg/d) in hemodialysis patients. however, it is unclear whether consumption of high amounts of protein in dialysis patients has beneficial or harmful nutritional and cardiovascular effects in this population. high protein intake might improve nutritional status, but it has been argued that the state of low muscle mass, small body size and low serum protein levels is not the result of decreased dietary intake, rather a result of hypercatabolism induced by metabolic acidosis, inflammation and oxidative stress. the specific aims of this study are to examine in a prospective cohort of hemodialysis patients the longitudinal associations of absolute total protein intake or dietary protein intake with muscle mass and arterial stiffness.

it is hypothesized that in the dialysis population overall: (1) protein intake is a major determinant of muscle mass while inflammation, oxidative stress and metabolic acidosis play a lesser role; (2) malnutrition is not an uremic cardiovascular risk factor hence low protein intake does not cause cardiovascular disease; and (3) in the other extreme, high protein intake is also not a major cause of cardiovascular disease since high serum phosphorus associated with high protein intake can usually be controlled by the use of phosphorus binders in routine clinical practice. the specific aims of this proposal are to examine in a prospective cohort of hemodialysis patients the longitudinal associations of absolute total protein intake (tpi) in grams/day, or dietary protein intake (dpi) normalized to body weight in grams/kilogram/day) with 1. nutritional status (mid-thigh muscle mass as measured by magnetic resonance imaging ) and functional status (6-min walk) and 2. arterial stiffness (aortic pulse wave velocity) understanding the relationship between protein intake with body composition (muscle mass) and intermediate cardiovascular outcomes (arterial stiffness) in stage 5 ckd patients in hemodialysis is of great scientific and practical significance

Eligibility criteria:
inclusion criteria: * adult stage 5 chronic kidney disease patients, on dialysis for at least 3 months. * urine output \> 200 ml/day exclusion criteria: * patients with persistent volume overload (substantial pedal edema) despite attempts at achieving dry weight * patients with inability to walk or who use a wheel-chair with reduced mid-thigh muscle mass * persons with pacemakers, cochlear implants, or other prohibitive conditions for magnetic resonance imaging * atrial fibrillation * patients who are unlikely or unable (in the opinion of the nephrologists, nurses or dieticians taking care of the patient) to comply with research protocol * patients with symptomatic heart failure, current active malignancy (excluding squamous and basal cell skin cancers), active aids, chronic lung disease requiring supplemental oxygen therapy and cirrhosis * patients enrolled in interventional trials

Keywords: hemodialysis
a pilot study of combined cycle ergometry and amino acids in the icu

Conditions: Acute Respiratory Failure

Summary: the purpose of this small pilot study is to refine a combined intervention of iv amino acids and cycle ergometry in critically ill patients, and to gather preliminary data, before proceeding with a larger multi-center rct. a total of 10 patients will receive the combined intervention.


Eligibility criteria:
inclusion criteria: 1. \>=18 years old 2. requiring mechanical ventilation or high flow nasal cannula (hfnc) with actual or expected total duration of mechanical ventilation or hfnc \>48 hours 3. expected icu stay \>4 days after enrollment (to permit adequate exposure to the proposed intervention) exclusion criteria: 1. \>120 continuous hours of mechanical ventilation or hfnc before enrollment 2. expected death or withdrawal of life-sustaining treatments within 7 days from enrollment 3. no expectation for any nutritional intake within the subsequent 72 hours 4. severe chronic liver disease (meld score \>20) or acute fulminant hepatitis. 5. documented allergy to the amino acid intervention 6. not ambulating independently prior to icu admission (use of gait aid permitted) 7. pre-existing primary systemic neuromuscular disease (e.g. guillain barre) 8. neuromuscular blocker infusion (eligible once infusion discontinued if other inclusion criteria met) 9. pre-existing intracranial or spinal process affecting motor function 10. pre-existing cognitive impairment or language barrier that prohibits outcomes assessment 11. lower extremity impairments that prevent cycling (e.g. amputation, knee/hip injury) 12. weight \>150kg 13. pregnant 14. incarcerated
use of cyclosporin a for the treatment of recurrent miscarriage

Conditions: Miscarriage, Recurrent

Summary: the purpose of this study is to determine whether cyclosporin a (csa) - an immunosuppressant drug - in early pregnancy will reduce the risk of miscarriage in women who had a history of unexplained recurrent miscarriages, as compared with that treated with dydrogesterone-an active comparator. the hypothesis is based on the evidence found in vitro and in vivo experiments that csa can induce maternal-fetal tolerance so that it may reduce the risk of miscarriage.


Eligibility criteria:
inclusion criteria: * both the woman and her husband agree to participate and sign the informed consent form. * have a history of two or more unexplained recurrent miscarriages. * spontaneous conception. * gestational age less than 5 weeks. * have a normal menstrual cycle (\>=23 and \<=35 days) and biphasic pattern of basal body temperature before pregnancy. * no significant chromosomal aberrations in the couple. * semen quality tests show not apparent abnormalities in husband exclusion criteria: * age below 18 or above 41 years at conception. * present pregnancy is a result of donor insemination or egg donation. * significant uterine anomalies detected by ultrasonography, hysterosalpingography, or hysteroscopy. * contraindications of csa (e.g. severe infectious diseases, tumor or immunodeficiency) or dydrogesterone. * smoking more than 20 daily.

Keywords: recurrent miscarriage; immunology
identification of molecular biomarkers for thyroid cancer

Conditions: Thyroid Cancer

Summary: this is a two part study; part a proposes to collect plasma samples to examine how ctdna (circulating thyroid dna) markers correlate with detection of recurrent disease, response to therapy, clinical outcome and pathological data. part b aims to use tissue obtained from biopsies of primary or recurrent disease to establish cell lines and tumour explants to further investigate the biology of thyroid cancer in the preclinical setting

to collect blood and tumour tissue for part a: molecular profiling, including extraction of dna for sequencing, rna for expression levels and to identify expressed fusion genes, and proteins for proteomic studies and part b: for establishment of cell lines and patient derived xenograft (pdx) models of thyroid cancer. 1. to correlate braf v600e, ras, ret/ptc, ret, pax8/pparϒ, βcatenin, p53, pten and pi3k mutations in ctdna with formalin fixed paraffin embedded tumour tissue (ffpe) mutational analysis. 2. to correlate the quantity of ctdna fragments 3 monthly in patients with advanced disease on routine follow up with conventional tumour markers (tg, calcitonin, cea). 3. to correlate the quantity of ctdna fragments 3 monthly once relapse suspected by conventional methods (tg, calcitonin, cea, radiological) 4. to correlate the quantity of ctdna fragments with response (recist, tg, calcitonin and cea) to targeted therapies 5. to assess prognostic significance of ctdna levels in metastatic/advanced thyroid cancer 6. to isolate live tumor cells for studies of novel treatment strategies (combinatorial treatments), therapy resistance and thyroid cancer biology 7. retrieval and analysis of archival primary tissue blocks for comparison with metastatic tumour sites 8. to collect blood for analysis of noninvasive tests of tumour phenotype

Eligibility criteria:
inclusion criteria: * t3-4, n0-1b, m0-m1 thyroid cancer (papillary, follicular, poorly differentiated, anaplastic and medullary thyroid carcinoma). * patient able to provide informed consent * patient attending the royal marsden hospital for inpatient or outpatient review * sufficient tissue sample available to perform analysis (archived or fresh) * adults \>16 years old exclusion criteria: * patients unable to provide informed consent * thyroid lymphoma * metastases to the thyroid * no histological confirmed diagnosis * only cytology available
the role of radial peripapillary vessel density in irvine-gass syndrome

Conditions: Cataract; Macular Edema

Summary: pseudophakic cystoid macular edema (pcme), also known as irvine-gass syndrome (igs), is an accumulation of fluid in the macula that occurs after cataract surgery, with an early or late presentation (cut-off 3 months) . it is the most common cause of decreased vision after uneventful phacoemulsification, with a rare incidence of 0.1-2.35% for clinically significant pcme . macular edema in igs can be diagnosed and classified by optical coherence tomography (oct), which enables its morphologic assessment. fluorescein angiography (fa) is the gold standard to perform differential diagnosis for macular edema. to date, oct angiography (octa) has been proposed to study various retinal vascular diseases. in contrast to fa, octa is able to visualize radial peripapillary vessel density (rcp). the aim of this study was to investigate abnormalities in the vascular network of the optic nerve head in patients with igs compared to healthy eyes, using oct-a


Eligibility criteria:
inclusion criteria: clinical diagnosis of pcme cataract surgery exclusion criteria: diabetes vein occlusion uveitis vasculitis age-related macular degeneration hereditary macular dystrophy -

Keywords: octa;rpc; igs;pcme
jab-21822 activity in adult patients with advanced solid tumors harboring kras g12c mutation

Conditions: Advanced Solid Tumor; NSCLC; CRC

Summary: this study is to evaluate the safety and tolerability of jab-21822 monotherapy and combination therapy in adult participants with advanced solid tumors harboring kras g12c mutation.

the primary objective of this study is to evaluate the safety and tolerability of jab-21822 monotherapy to determine the mtd and pr2d during dose escalation phase; then to evaluate preliminary antitumor activity when jab-21822 administered alone and combination with cetuximab during dose expansion phase in adult participants with advanced solid tumors harboring kras g12c mutation.

Eligibility criteria:
inclusion criteria: * participants must be able to provide an archived tumor sample * histologically or cytologically confirmed solid tumors with kras g12c mutation * must have received at least 1 prior standard therapy * must have at least 1 measurable lesion per recist v1.1 * must have adequate organ function * must be able to swallow and retain orally administered medication exclusion criteria: * has brain or spinal metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days * active infection requiring systemic treatment within 7 days * active hbv or hcv * any severe and/or uncontrolled medical conditions * lvef ≤50% assessed by echo or qtcf * qt interval \>470 msec * experiencing unresolved ctcae 5.0 grade \>1 toxicities

Keywords: kras g12c mutant advanced solid tumor; nsclc; crc
exploratory study to assess the short term intratumoural and peripheral effects of bn83495 in postmenopausal women with newly diagnosed breast cancer

Conditions: Breast Cancer

Summary: this trial will assess the intratumoural pharmacological activity of bn83495 by changes in intratumoural levels of sex hormones and associated inhibition of steroid sulphatase (sts) activity.


Eligibility criteria:
inclusion criteria: * female subjects 55 to 80 years with histologically or cytologically documented primary intraductal or lobular invasive breast cancer that meets the following criteria: * t2, n0 or n1, m0. * primary tumour clinically determined to be 2 to 5 cm in the greatest dimension. * laboratory documentation of positive oestrogen receptor (er+) status in at least 10% of the tumour cells. * laboratory documentation of her-2 negative status. postmenopausal defined as * no spontaneous menses for a total of 2 years * amenorrheic for at least 12 months with serum oestrogen level \ 20 iu/l, chemotherapy-induced amenorrhoea for at least 12 months * bilateral oophorectomy, or radiation castration and amenorrhoeic for at least 3 months. eastern cooperative oncology group (ecog) performance status ≤2. exclusion criteria: * has locally advanced breast cancer that is considered non-operable without neoadjuvant therapy. * has evidence of metastatic disease * as a diagnosis of inflammatory breast cancer * has ductal carcinoma in situ
post market study to collect data for software recognizing the anatomical structures during bronchoscopy.

Conditions: Tumor; Hemoptysis; Pulmonary Disease

Summary: the primary aim is to develop a software algorithm that has the capacity to detect the normal 18 anatomical structures of the lung by using the position of the scope during the bronchoscopy procedure and using existing bronchoscopy technology.

2.000 subjects, preferable 150-200 number of patients per site. the 2.000 videos will be divided into an 80%/20% split (training and testing). it is a wish to obtain a spread of videos coming from across europe, preferable from germany, france and denmark, with up to 800 videos coming from denmark the patient population indicated are patients indicated for full airway bronchoscopy. of this group it is the aim to enrol the following: 1. patients with obstructing tumors (when tumor blocks the view of the camera) - no more than 5% (120 patients) of studies 2. bronchoscopies on indication of haemoptysis (active bleeding) - no more than 5% (120 patients) of studies 3. patients with stents or valves - no more than 5% (120 patients) of studies bronchoscopies. 4. patients with former lung operations, partial or full resections - no more than 2% (48 patients).

Eligibility criteria:
inclusion criteria: 1. oral and written participant information has been given (na for denmark) 2. the subject has signed informed consent (na for denmark) 3. patients indicated for full airway bronchoscopy (identifying all 18 anatomical segments) 4. patients older than 18 exclusion criteria: 1. subject with serious lung disease which investigator considers not appropriate for this examination. 2. lack of patient cooperation for bronchoscopy (patient with mental disorders, dysgnosia, psychological disorder...) 3. subjects unable to give consent (na for denmark)

Keywords: bronchoscope
the vitamin b status in type 2 diabetes (vita) study

Conditions: Diabetes Mellitus, Type 2; Vitamin B 12 Deficiency; Vitamin B 6 Deficiency

Summary: the objective of this study was to evaluate vitamin b deficiency (particularly vitamin b6 deficiency) in diabetic patients in germany in relation to the presence or absence of proteinuria, and global vascular risk.

this observational study recruited either control subjects or patients with type 2 diabetes for over 5 years and collected information on cardiovascular risk factors. fasting blood samples and urine were collected and biomarkers of b-vitamins were measured and were related to renal function or to global cardiovascular risk. global cardiovascular risk was calculated from established models that include routine clinical and laboratory markers such as plasma lipids, smoking, hypertension, and bmi. we measured the following markers: glucose (fasting plasma glucose); hba1c; serum creatinine; glomerular filtration rate (gfr), urinary albumin, c-reactive protein, soluble vascular cell adhesion molecule 1 (svcam-1), cystatin c, vitamin b1, vitamin b12, holotranscobalamin, methylmalonic acid, homocysteine, and different vitamin b6 forms.

Eligibility criteria:
inclusion criteria: 1. written informed consent before any study-related activities 2. ambulatory subject \>18 years of age for patients with type 2 diabetes: 3. duration of diabetes ≥ 5 years 4. glycated haemoglobin (hba1c) \<10% 5. body mass index (bmi) 19-40 kg/m2 for healthy controls: 6. no diabetes (normal fasting glucose levels measured by stick) exclusion criteria: 1. end stage renal disease (creatinine clearance \<10 ml/min) 2. severe excess alcohol consumption (\>50 units/week) 3. severe co-morbidities 4. renal and/or pancreatic transplant 5. vitamin b1, b6 and/or b12 substitution (incl. multivitamin preparations) 6. participation in an interventional study within 30 previous days; 7. patient is female and pregnant or lactating 8. patient is female in a childbearing age without adequate contraceptive precaution
rheumatoid arthritis patients at risk for interstitial lung disease

Conditions: Rheumatoid Arthritis; Interstitial Lung Disease

Summary: the overall goal of this study is to define the phenotype of interstitial lung disease (ild), and identify factors that predict radiologic progression in those with subclinical ra-ild, in patients with rheumatoid arthritis (ra). the investigators hypothesize that there are common core elements (e.g. clinical features, genetic variants, and/or biologic markers) between other forms of ild (e.g. idiopathic pulmonary fibrosis, ipf) and subclinical ra-ild that places individuals at risk for the development of lung disease.


Eligibility criteria:
inclusion criteria: 1. ≥ 45years old 2. diagnosis of ra using the 2010 american college of rheumatology (acr) criteria exclusion criteria: 1. inability to give informed consent 2. pregnant women 3. history of interstitial lung disease 4. evidence of other causes of diffuse parenchymal lung disease such as infection, drug toxicity, other autoimmune processes, etc. 5. subjects over the age of 90 years old or less than 45 years old

Keywords: rheumatoid arthritis ra interstitial lung disease ild lung disease connective tissue disease ctd idiopathic pulmonary fibrosis ipf airways disease
health system dynamic & resource requirement in a south african covid-19 field hospital

Conditions: Field Hospitals; COVID-19 Pandemic; Health Systems; Global Health; Health Resources; Low-Income Population

Summary: the aim of this study is to describe the patient clinical profile, resource requirements, and health system dynamics in a field hospital during the second wave of the coronavirus (covid-19) pandemic, leading to the outbreak of viral severe acute respiratory syndrome (sars-cov-2 virus), in south africa. by describing the field hospital in this unique setting, the investigators hope to provide an efficient guide to similar settings across low- and middle-income countries. this was a retrospective, single-center study. a total of 596 patients with confirmed covid-19 were admitted to mitchells plain hospital of hope (mphoh), cape town, south africa, between january 1st and february 28th, 2021. patient clinical characteristics, outcome, and resource allocation was collected. daily hospital dynamics, including admissions, discharges, deaths and oxygen use was analyzed and compared to the local and national covid-19 incidence rates.

the aim of the study is to amplify what is known about field hospitals in resource-constrained setting, so as to guide meaningfully the future covid-19 public health response. understanding not only the patient profile, but clinical resource requirements, and health system dynamic in a south african field hospital during the second wave of the covid-19 pandemic can help in preparation for a future infection surge. this will shed light on the extent and timing of excess demand for intermediate care facilities for covid-19 during peak infection periods in this region. furthermore, lessons learnt here can guide efforts in similar settings across low-and middle-income countries. data was collected on all patients admitted to mphoh between january 1st and february 28th 2021 using notes from patient folders' and an electronic hospital records systems. patient demographics, clinical profile, resource utilization; as well as the hospital dynamics were collected. covid-19 incidence rates were collected from the national institute for infectious diseases, south africa a descriptive data analysis was performed to report the number, mean, median, and range of all relevant values. hospital level data were summarized into weekly intervals, described and compared to covid-19 incidence rates. statistical data analysis was performed using r statistical computing program and microsoft excel.

Eligibility criteria:
inclusion criteria: * all patients admitted to the mitchells plain hospital of hope covid-19 field hospital between 1st january 2021 and 29th february 2021. patients admitted to the hospital must have been: over 18years of age, diagnosed with covid-19 via polymerase chain reaction (pcr) test, transferred from a referring facility. exclusion criteria: * no patients were excluded.